Lyfo-Kwik (TM) Coagulase Plasma
FDA 510(k) K861312 · Micro-Bio-Logics
510(k) numberK861312
Submission
- Device name
- Lyfo-Kwik (TM) Coagulase Plasma
- Applicant
- Micro-Bio-Logics
St. Cloud, MN, US - Received
- April 8, 1986
- Decision date
- April 18, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTL – Plasma, Coagulase, Human, Horse And Rabbit
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2160
- Specialty
- Microbiology
Other 510(k)s with product code JTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950706 | Dryslide CoagulaseJTL · Traditional | Difco Laboratories, Inc. | 05/16/1995SE |
| K883333 | Rabbit Plasma Fibrinogen (RPF) SupplementJTL · Traditional | Immuno-Mycologics, Inc. | 08/25/1988SE |
| K870945 | Rabbit Plasma Fibrinogen Supplement SR 122JTL · Traditional | Oxoid U.S.A., Inc. | 06/10/1987SE |
| K840553 | HemastaphJTL · Traditional | Remel Co. | 04/13/1984SE |
| K833988 | Api Staphase IIIJTL · Traditional | Analytical Products, Inc. | 12/22/1983SE |
| K833858 | Coagulase Plasma, Horse & Rabbit EdtaJTL · Traditional | Otisville Biotech, Inc. | 12/08/1983SE |
| K822988 | Coagulase Plasma-Citrated & EdtaJTL · Traditional | American Scientific Products | 11/05/1982SE |
| K820177 | Coagulase PlasmaJTL · Traditional | Quadroma, Inc. | 02/05/1982SE |
| K812602 | Rabbit Coagulase PlasmaJTL · Traditional | Dutchland Laboratories, Inc. | 09/29/1981SE |
| K811982 | Staphase*JTL · Traditional | Analytical Products, Inc. | 07/28/1981SE |
More from Analytical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K870731 | Lyfo Kwik(Tm) Rus KitJXA · Traditional | 06/17/1987SE |
| K861022 | Kwik Stik(Tm) Lyfo(Tm) Disk MicroorganismsJTR · Traditional | 04/04/1986SE |
| K855172 | Kwi (TM) G-Co/TwoJSK · Traditional | 02/20/1986SE |
| K855198 | Indi Kwik (TM) Co/Two KitJTR · Traditional | 01/14/1986SE |
| K852998 | Neisseria - Kwik PlusJSX · Traditional | 07/23/1985SE |
| K851978 | Lyfo-Kwik Omi KitJSS · Traditional | 06/04/1985SE |
| K844014 | Ono/Co-Two (TM) SystemsJTY · Traditional | 10/31/1984SE |
| K842129 | Lyfo-Disk MicroorganismsJTR · Traditional | 07/03/1984SE |
Questions and answers
When was Lyfo-Kwik (TM) Coagulase Plasma cleared by the FDA?
Lyfo-Kwik (TM) Coagulase Plasma (K861312) received a 510(k) decision of Substantially Equivalent on April 18, 1986, 10 days after the submission was received.
What is the product code of K861312?
The FDA product code is JTL – Plasma, Coagulase, Human, Horse And Rabbit, a Class I (low risk) device regulated under 21 CFR 866.2160.